TGA EU consultations
February 18, 2014
The Therapeutic Goods
Administration has launched a
series of consultations on whether
Australia should adopt several
European Union guidelines.
The closing date for the
consultation is 28 Mar 2014,
with 11 EU guidelines under
consideration.
These include guidelines on
the evaluation of medicinal
products indicated for bacterial
infections, on the clinical
evaluation of antifungal agents,
on the evaluation of anticancer
medicinal products, and on clinical
investigation of medicinal products
in the treatment or prevention of
diabetes mellitus.
Biological guidelines are also
included, such as on the quality
of biological active substances
produced by transgene expression
in animals and in higher plants, plus
a guideline on similar biological
medicinal products containing
monoclonal antibodies.
There’s also a guideline on ADHD
products and pandemic influenza
marketing - CLICK HERE for details.
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